Stress-reducing Intervention in Urothelial Carcinoma
ConditionBladder Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorComenius University
About this trial
The aim of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in patients with muscle-infiltrating bladder carcinoma (MIBC) treated with chemotherapy based on cisplatin in neoadjuvant setting followed by local therapy (standard of care, SOC) compared to SOC alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients older than 18 years.
Evidence of muscle-infiltrating urothelial bladder carcinoma (including variants) by biopsy.
No prior chemotherapy.
No previous malignancy, except for basal-cell carcinoma of the skin within last 5 years.
Disqualifiers
Diabetes mellitus with symptomatic neuropathy.
Using antiarrhythmic drugs, opiates and/or antidepressants.
Implanted permanent pacemaker (PPM).
Human Immunodeficiency Virus (HIV) infection.
Trial design
Design model
Parallel
Treatments tested in this trial
HRV biofeedback
Other interventionDaily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Heart-rate variability (HRV) biofeedback intervention + standard of careExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Primary Objective: Inflammation
The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on inflammation (IL-6, Tumor necrosis factor α, IL-10 in pg/ml).
Time frame
36 months2
Primary Objective: Heart Rate Variability (HRV)
The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on HRV indexed by the root mean square of successive differences between heartbeats (RMSSD) in ms.
Time frame
36 months3
Primary Objective: Quality of Life (QoL)
The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on EORTC-QLQ-C30 (version 3) score. The EORTC-QLQ-C30 has 30 items divided into five functional scales (physical, role, cognitive, emotional, and social), and three symptom scales (fatigue, pain, and nausea and vomiting). The score for each scale as well as the sum score for the whole instrument is standardized to values 0 to 100, with a higher score meaning a worse outcome.
Time frame
36 months4
Primary Objective: Working memory
The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on working memory measured by digit span test score (the number of remembered digits in the longest passed sequence), for both forward and backward condition.
Time frame
36 monthsSecondary outcomes
1
Secondary objective: Serious Adverse Events
The effect of 3-months heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on serious adverse events (SAEs) of chemotherapy.
Time frame
36 months2
Secondary objective: Disease-Free Survival (DFS)
The effect of 3-months heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on disease-free survival (DFS).
Time frame
60 months3
Secondary objective: Overall Survival (OS)
The effect of 3-months heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on overall survival (OS).
Time frame
60 monthsSponsors and contacts
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Source ClinicalTrials.gov